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Ketoconazole API bulk supplier for pharma manufacturers

Ketoconazole API Suppliers & Bulk Manufacturers

Available Forms: White to off-white crystalline powder

Available Strengths: High-purity powder with assay typically 98% or higher (USP / EP / BP)

Reference Brands: Nizoral (US/EU)

Category: Active Pharmaceutical Ingredient

Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections. It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus.

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Product Description:

Ketoconazole is a broad-spectrum imidazole antifungal API used in the production of oral tablets, topical creams, lotions, and shampoos. It inhibits the synthesis of ergosterol, a vital component of fungal cell membranes, making it effective against various superficial and systemic fungal infections.

Buying an API? See what to check in an API supplier: the DMF or CEP, written confirmation for the EU, GMP evidence and the Certificate of Analysis.

Ketoconazole API — third party manufacturing & bulk supply

Ketoconazole API is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Ketoconazole API is supplied as White to off-white crystalline powder — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Ketoconazole API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Ketoconazole API is listed as White to off-white crystalline powder in High-purity powder with assay typically 98% or higher (USP / EP / BP). Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Ketoconazole API is referenced against Nizoral (US/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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